TIVICAY PD Dosage & Rx Info | Uses, Side Effects

Tivicay Pd Generic Name & Formulations

Legal Class

General Description

Dolutegravir 5mg; tabs for oral susp.

Pharmacological Class

HIV-1 integrase strand transfer inhibitor (INSTI).

How Supplied

Tabs—30; PD—60 (w. dosing cup + oral dosing syringe)

Manufacturer

ViiV Healthcare

Generic Availability

Mechanism of Action

Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral DNA integration which is essential for the HIV replication cycle.

Tivicay Pd Indications

Indications

In combination with other antiretroviral agents for treatment of HIV-1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) aged ≥4weeks and weighing ≥3kg.

Tivicay Pd Dosage and Administration

Adult

Use other form.

Children

See full labeling. <4weeks, <3kg, or INSTI-experienced with documented or clinically suspected resistance to other INSTIs (eg, raltegravir, elvitegravir): not established. Swallow the tabs for oral susp whole or fully disperse in (5mL or 10mL based on dose) drinking water. After dispersion, administer susp within 30mins of mixing. ≥4weeks: (3–<6kg): 5mg once daily; (6–<10kg): 15mg once daily; (10–<14kg): 20mg once daily. (14–<20kg): 25mg once daily; (≥20kg): 30mg once daily. If concomitant with certain UGT1A or CYP3A inducers, increase weight-based dose to twice daily.

Tivicay Pd Contraindications

Contraindications

Concomitant dofetilide.

Tivicay Pd Boxed Warnings

Not Applicable

Tivicay Pd Warnings/Precautions

Warnings/Precautions

Tabs and tabs for oral susp are not interchangeable on a mg per mg basis. Discontinue if hypersensitivity reactions develop. Increased risk for worsening/development of elevated transaminases in patients with underlying hepatitis B or C; monitor for hepatotoxicity. Severe hepatic impairment: not recommended. INSTI-experienced patients (with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance) with severe renal impairment: may result in loss of efficacy and development of resistance. Dialysis. Elderly. Pregnancy. Nursing mothers: see full labeling for potential risks in infants.

Tivicay Pd Pharmacokinetics

Absorption

Peak plasma concentrations were observed 1–3 hours postdose. Steady state is achieved within ~5 days.

Distribution

Apparent volume of distribution: 17.4 L (after a 50mg once daily dose). Plasma protein bound: ≥98.9%.

Metabolism

UGT1A1 (primarily), CYP3A.

Elimination

Fecal (53%), renal (31%). Half-life: ~14 hours. Apparent clearance: 1.0 L/hr.

Tivicay Pd Interactions

Interactions

Avoid concomitant nevirapine, oxcarbazepine, phenytoin, phenobarbital, St. John’s wort. Avoid etravirine unless coadministered with atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir. Concomitant efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, rifampin, or carbamazepine: adjust dose (see Adults, Children). May be affected by drugs that induce or inhibit UGT1A1, UGT1A3, UGT1A9, BCRP, and P-gp enzymes or transporters. May potentiate drugs eliminated via OCT2 or MATE1 (eg, dofetilide, dalfampridine, metformin). Concomitant cation-containing antacids, laxatives, sucralfate, buffered drugs, or oral iron/calcium supplements (also can give together with a meal): give dolutegravir 2hrs before or 6hrs after.

Tivicay Pd Adverse Reactions

Adverse Reactions

Insomnia, fatigue, headache; hypersensitivity reactions, hepatotoxicity, immune reconstitution syndrome.

Tivicay Pd

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